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Walter E. Washington Convention Center

Jun 14, 2015 2:30 PM - Jun 18, 2015 6:45 PM

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

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Can We Talk? Alternative Strategies for Communicating with FDA

Session Chair(s)

Kim Quaintance-Lunn

Vice President, Regulatory Affairs Americas

Bayer AG, United States

Experienced regulatory professionals know that formal meetings are insufficient to address all the issues that arise during drug development. Our panel will discuss best practices and innovative ways to ensure optimal communications with FDA.

Learning Objective : Identify available avenues for communication with FDA; Evaluate opportunities to maximize effective interactions with FDA; Formulate strategic plans around communicating with FDA.

Speaker(s)

Consultant Perspective

Mark Ammann, PharmD

Quantum Regulatory Solutions, LLC, United States

President

Industry Perspective

Khyati Roberts, RPh

Retired, United States

Retired

FDA Perspective

Rachel E. Hartford

FDA , United States

Lead Consumer Safety Officer, Office of New Drugs, CDER

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Ways to register

Registration override should work.